Metabolic SyndromeCOGNEX-2NCT01906957
Cognition and Exercise Training
A study testing high intensity interval training (HIIT) and moderate intensity continuous exercise training in people with Metabolic Syndrome and Coronary Heart Disease, run by Montreal Heart Institute at 2 sites in Canada.
Trial summary
The aim of study is to investigate the impact of two different training modalities (high intensity interval training (HIIT) versus moderate intensity continuous exercise training (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness in older healthy adults, patients with metabolic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Coronary Heart Disease, Chronic Heart Failure
- What is being tested?
- high intensity interval training (HIIT) and moderate intensity continuous exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2013to 9 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living.
- Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated criteria: presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l.
- CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy).
- Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:
- ≥18 years
- Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by MUGA Scan, echo or radiological ventriculography)
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- NYHA functional class I-III
- Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation).
- Able to perform an symptom limited exercise test.
- Capacity and willingness to sign the informed consent form.
Who cannot join
- For healthy elderly subjects:
- age under 60 years
- lack of expressed written consent
- metabolic syndrome
- coronary heart disease
- chronic systolic heart failure
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- resting left ventricular ejection fraction < 40 %
- symptomatic aortic stenosis
- chronic atrial fibrillation
- malignant exertional arrhythmias
- non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
- severe exercise intolerance.
- For patients with metabolic syndrome:
- lack of expressed written consent
- coronary heart disease
- chronic systolic heart failure
- resting left ventricular ejection fraction < 40 %
- symptomatic aortic stenosis
- chronic atrial fibrillation
- malignant exertional arrhythmias
- non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
- severe exercise intolerance.
- For patients with CHD
- lack of expressed written consent
- recent acute coronary event (< 3 months)
- chronic systolic heart failure
- resting left ventricular ejection fraction < 40 %
- symptomatic aortic stenosis
- severe non-revascularize coronary disease including left main coronary stenosis
- patient awaiting coronary artery bypass surgery
- chronic atrial fibrillation
- presence of permanent ventricular pacemaker
- malignant exertional arrhythmias
- non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
- severe exercise intolerance.
- For CHF patients:
- Any relative or absolute contraindications to exercise training among patients with stable chronic heart failure according to current recommendations (Working Group on Cardiac Rehabilitation 2001)
- Fixed-rate pacemaker or ICD devices with heart rate limits set lower than the exercise training target heart rate.
- Major cardiovascular event of procedure within the 3 months preceding enrolment in the study.
- Atrial fibrillation
- Heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction)
- Heart failure secondary to congenital heart disease or obstructive cardiomyopathy.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute
Montreal, Quebec, H1T 1N6
Cardiovascular Prevention and Rehabilitation Centre (EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
Official title: Cerebral Oxygenation, Cardiac Output,Cognitive Function, and Exercise Training in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure.
The aim of study is to investigate the impact of two different training modalities (high intensity interval training (HIIT) versus moderate intensity continuous exercise training (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart failure. The investigators hypothesized that HIIT modality will lead to a larger improvement in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke volume) and cognitive performance at rest and during submaximal exercise. The primary endpoint will be the improvement in cognitive performance.
- Being tested
- high intensity interval training (HIIT), moderate intensity continuous exercise training
- Medical subject headings
- Metabolic Syndrome, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity interval training (HIIT)Other
High-intensity interval exercise (HIIE) session This HIIE session will be based on a previous study conducted in our laboratory that compared physiological, psychological and electrocardiological tolerance of four different single bouts of HIIE in coronary patients (Guiraud et al. 2010). The selected HIIE session represented the best compromise between safety, time spent at a high level of VO2peak and psychological adherence. This HIIE session consists of a 10-min warm-up at 50% of MAP, followed by two sets of 10 min composed of repeated bouts of 15 s at 100% of MAP interspersed by 15 s of passive recovery. Four minutes of passive recovery were allowed between the two sets, as well as a 5-min cool-down after the last 15-s exercise bout. A total duration of 35 minutes will be employed for this session for coronary artery disease patients, and 22 minutes for chronic heart failure patients (Guiraut et al. 2010 b).
moderate intensity continuous exercise trainingOther
Moderate Intensity Continuous Exercise (MICE) session This exercise session will be based on the recommendations of the American Heart Association on exercise prescription in cardiac rehabilitation (Balady et al. 2007), suggesting that exercise intensity should lie between 50% and 80% of maximal aerobic power (MAP). We opted for an intensity of 70% of MAP. Duration will be adjusted to match total energy expenditure of the HIIE, according to the previous methodology method (Guiraud et al. 2010 b). A total duration of 28.7 minutes will be employed in healthy elderly patients, coronary artery disease patients and patients with metabolic syndrom; and 16 minutes in chronic heart failure patients.
| Study group | Role | What they receive |
|---|---|---|
| Elderly healthy subjects | Experimental | Randomization into :
1. high intensity interval training (HIIT)(n=20)
or
2. moderate intensity intensity continuous exercise (n=20) Receives: Other: high intensity interval training (HIIT); Other: moderate intensity continuous exercise training |
| Patients with metabolic syndrome | Experimental | Randomization into :
1. high intensity interval training (HIIT)(n=20)
or
2. moderate intensity intensity continuous exercise (n=20) Receives: Other: high intensity interval training (HIIT); Other: moderate intensity continuous exercise training |
| coronary patients | Experimental | Randomization into :
1. high intensity interval training (HIIT)(n=20)
or
2. moderate intensity intensity continuous exercise (n=20) Receives: Other: high intensity interval training (HIIT); Other: moderate intensity continuous exercise training |
| heart failure patients | Experimental | Randomization into :
1. high intensity interval training (HIIT)(n=20)
or
2. moderate intensity intensity continuous exercise (n=20) Receives: Other: high intensity interval training (HIIT); Other: moderate intensity continuous exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function assessed by standard pen-paper battery test
- Digit Span (Forward and Backward) (short-term and working memory), b) Digit Symbol Substitution Test (attention \& processing speed), c) Trail making test, part A and B (mental flexibility), d) D-KEFS Color-Word Interference Stroop Test (selective attention and inhibition) and e) Rey Auditory Verbal Learning Test (long-term verbal memory).
Measured: At baseline and after 3 months
Secondary outcomes (1)
Maximal aerobic capacity (VO2max)
Gas exchanges will be measured during maximal incremental test. The highest value reached during the exercise phase of the maximal test (ergocycle) will be considered as the VO2max.
Measured: At baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2018
- Study completion9 Sep 2022
Why it stopped: Not sufficient financial - staff resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu Gayda, Montreal Heart Institute
- Investigators
- Mathieu Gayda, Ph.D, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906957
- Sponsor's protocol ID
- COGNEX-2
- Acronym
- COGNEX-2
- Status last verified
- Sep 2022
- First submitted
- 11 Jul 2013
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation, Cardiac Output,Cognitive Function, and Exercise Training in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT01906957
- Acronym / sponsor ID
- COGNEX-2 / COGNEX-2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not sufficient financial - staff resources
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to investigate the impact of two different training modalities (high intensity interval training (HIIT) versus moderate intensity continuous exercise training (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart failure. The investigators hypothesized that HIIT modality will lead to a larger improvement in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke volume) and cognitive performance at rest and during submaximal exercise. The primary endpoint will be the improvement in cognitive performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elderly healthy subjects | Experimental | Other: high intensity interval training (HIIT), Other: moderate intensity continuous exercise trainingRandomization into : 1. high intensity interval training (HIIT)(n=20) or 2. moderate intensity intensity continuous exercise (n=20) |
| Patients with metabolic syndrome | Experimental | Other: high intensity interval training (HIIT), Other: moderate intensity continuous exercise trainingRandomization into : 1. high intensity interval training (HIIT)(n=20) or 2. moderate intensity intensity continuous exercise (n=20) |
| coronary patients | Experimental | Other: high intensity interval training (HIIT), Other: moderate intensity continuous exercise trainingRandomization into : 1. high intensity interval training (HIIT)(n=20) or 2. moderate intensity intensity continuous exercise (n=20) |
| heart failure patients | Experimental | Other: high intensity interval training (HIIT), Other: moderate intensity continuous exercise trainingRandomization into : 1. high intensity interval training (HIIT)(n=20) or 2. moderate intensity intensity continuous exercise (n=20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living.
- Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated criteria: presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l.
- CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy).
- Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:
- ≥18 years
Key exclusion criteria (42 listed)
- For healthy elderly subjects:
- age under 60 years
- lack of expressed written consent
- metabolic syndrome
- coronary heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high intensity interval training (HIIT)High-intensity interval exercise (HIIE) session This HIIE session will be based on a previous study conducted in our laboratory that compared physiological, psychological and electrocardiological tolerance of four different single bouts of HIIE in coronary patients (Guiraud et al. 2010). The selected HIIE session represented the best compromise between safety, time spent at a high level of VO2peak and psychological adherence. This HIIE session consists of a 10-min warm-up at 50% of MAP, followed by two sets of 10 min composed of repeated bouts of 15 s at 100% of MAP interspersed by 15 s of passive recovery. Four minutes of passive recovery were allowed between the two sets, as well as a 5-min cool-down after the last 15-s exercise bout. A total duration of 35 minutes will be employed for this session for coronary artery disease patients, and 22 minutes for chronic heart failure patients (Guiraut et al. 2010 b). | Other | Elderly healthy subjects, Patients with metabolic syndrome, coronary patients, heart failure patients |
| moderate intensity continuous exercise trainingModerate Intensity Continuous Exercise (MICE) session This exercise session will be based on the recommendations of the American Heart Association on exercise prescription in cardiac rehabilitation (Balady et al. 2007), suggesting that exercise intensity should lie between 50% and 80% of maximal aerobic power (MAP). We opted for an intensity of 70% of MAP. Duration will be adjusted to match total energy expenditure of the HIIE, according to the previous methodology method (Guiraud et al. 2010 b). A total duration of 28.7 minutes will be employed in healthy elderly patients, coronary artery disease patients and patients with metabolic syndrom; and 16 minutes in chronic heart failure patients. | Other | Elderly healthy subjects, Patients with metabolic syndrome, coronary patients, heart failure patients |
Primary outcome
Cognitive function assessed by standard pen-paper battery test
Time frame: At baseline and after 3 months
a) Digit Span (Forward and Backward) (short-term and working memory), b) Digit Symbol Substitution Test (attention \& processing speed), c) Trail making test, part A and B (mental flexibility), d) D-KEFS Color-Word Interference Stroop Test (selective attention and inhibition) and e) Rey Auditory Verbal Learning Test (long-term verbal memory).
1 secondary outcome
Maximal aerobic capacity (VO2max)
Time frame: At baseline and after 3 months
Results and safety
The study was stopped early (reason given: Not sufficient financial - staff resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Gayda, Ph.D principal investigator
Montreal Heart Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity interval training (HIIT) and moderate intensity continuous exercise training in people with Metabolic Syndrome and Coronary Heart Disease, run by Montreal Heart Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not sufficient financial - staff resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function assessed by standard pen-paper battery test (time frame: At baseline and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.